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510(k) Data Aggregation
(357 days)
Q Distal Access Catheter
The Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
The Q Distal Access Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.
The medical device described, the Q Distal Access Catheter, is not an AI/ML powered device, therefore, the requested information regarding AI/ML related aspects (such as effect size, standalone performance, training set details, and expert qualifications for ground truth) is not applicable. The provided text details the non-clinical performance testing for a physical medical catheter.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Q Distal Access Catheter are derived from various non-clinical performance tests, including bench testing and biocompatibility testing. The "Results" column from the provided tables serves as the reported device performance, indicating that the device "Pass"ed each criterion.
| Test Category | Specific Test | Acceptance Criterion (Test Method Summary) | Reported Device Performance (Result) |
|---|---|---|---|
| Bench Testing | Label Integrity | Device labels were evaluated to ensure labels are intact and legible after environmental conditioning, distribution simulation and aging. | Pass |
| Bubble Leak | Device packaging was evaluated to detect gross leaks in packaging. | Pass | |
| Pouch Seal Strength | Pouch was evaluated for the mechanical strength of the seal. | Pass | |
| Coating Particulate | The number and size of particles generated during simulated use were measured. | Pass | |
| Dimensional Verification | Dimensional specifications were verified to ensure device meets all the requirements. | Pass | |
| Tip Inspection | Catheter tip was evaluated to ensure the complete retrieval of tip during its removal. | Pass | |
| Surface Integrity | Device visually inspected to ensure surface is free of defects that can cause tissue trauma. | Pass | |
| Heat Shrink Inspection | To ensure heat shrink identifier remains intact and legible after environmental conditioning, distribution simulation and aging. | Pass | |
| Coating Uniformity | To evaluate the devices for uniform coating. | Pass | |
| Simulate Use/Compatibility | The catheter performance was evaluated when used in conjunction with other devices used in standard procedures without sustaining damage or kinks and without causing damage to the other devices. | Pass | |
| Coating Adhesion | To visually categorize the integrity of coating on the device. | Pass | |
| Push/Track | To ensure device is able to be tracked without kink under normal conditions in tortuous anatomy. | Pass | |
| Kink Resistance | The distal shaft of the device was evaluated for kink resistance when subjected to a bend radius of 1.0 cm. | Pass | |
| Liquid Leak Under Pressure | To ensure device does not exhibit leakage of liquid under a minimum pressure of 44 psi for a minimum of 30 seconds. | Pass | |
| Static Burst | To ensure device withstands a minimum pressure of 100 psi prior to burst. | Pass | |
| Tensile Strength - Push Wire | To ensure device meets the required tensile strength between the push wire and catheter body: 15 N pull force minimum. | Pass | |
| Tensile Strength - Distal Section | To ensure device meets the required tensile strength of the distal section of the shaft: 5N pull force minimum. | Pass | |
| Biocompatibility | Cytotoxicity | Biological reactivity Grade 0 on the test article after 48 hrs. incubation with mouse fibroblast. The response on the positive and negative control article extracts confirmed the suitability of the tests. The test article (TA) is considered non-cytotoxic. | Pass |
| Hemolysis (Direct and Indirect) | The test article in direct contact with blood had a hemolytic index of 0.3%, and the test article extract had a hemolytic index of 0.2%. Both the test article in direct contact with blood and the test article extract were non-hemolytic. | Pass | |
| Sterilization | Ethylene Oxide (EO) Residuals | In accordance with ISO 10993-7. | Pass (Implied by Conclusion) |
| Limulus Amoebocyte Lysate (LAL) | In accordance with USP 24 chapter 85 and FDA guidance. | Pass (Implied by Conclusion) | |
| Bioburden Testing | In accordance with relevant standards (not explicitly listed but implied alongside EO residuals and LAL). | Pass (Implied by Conclusion) | |
| Shelf-life | Shelf-life Verification (3 years) | The device will be labeled with an expiration date of 3 years from the date of sterilization. | Pass (Implied by Conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific bench or biocompatibility test. The evaluation involved "design verification testing" and "additional biocompatibility testing." The provenance of the data is from internal testing conducted by MIVI Neuroscience, Inc., as part of their 510(k) submission. This is considered retrospective for the purpose of the submission, as the tests were performed to demonstrate compliance of an already designed and manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the Q Distal Access Catheter is a physical medical device, not an AI/ML powered device that relies on expert interpretation for "ground truth" establishment in its performance evaluation. The "ground truth" in this context refers to established engineering specifications, material science standards, and biocompatibility guidelines.
4. Adjudication Method for the Test Set
This question is not applicable for a physical medical device. The "adjudication method" concept is typically used for subjective assessments in clinical or AI/ML studies where human interpretation of ambiguous data is involved. For engineering and scientific testing of a physical device, results are typically objective and determined by established protocols and measurement techniques.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not have a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Q Distal Access Catheter's performance evaluation is based on a combination of:
- Design Specifications: Predefined engineering requirements and dimensional tolerances for the catheter.
- Established Industry Standards: Such as ISO 11135:2014 for sterilization, ISO 10993-7 for biocompatibility residuals, ASTM F756 for hemolysis, and USP 24 chapter 85 for bacterial endotoxins.
- Visual and Mechanical Inspection Criteria: Standardized methods to assess physical integrity, coating uniformity, and functional performance.
- Physiological Response Criteria: For biocompatibility, established thresholds for cytotoxicity and hemolysis.
8. The Sample Size for the Training Set
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.
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(136 days)
MIVI Q Distal Access Catheter
The MIVI Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
The MIVI Q Distal Access Catheter (Q Catheter) is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MIVI Q Distal Access Catheter:
The document provided is a 510(k) Summary for the MIVI Q Distal Access Catheter, which is a premarket notification to the FDA for a medical device seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving novel effectiveness.
Given the nature of a 510(k) submission for a catheter, the "acceptance criteria" and "device performance" in this context refer to the ability of the device to meet specified engineering and biocompatibility standards, and to perform its intended function without significant differences from the predicate. There is no clinical study in the traditional sense (e.g., patient trials with efficacy endpoints) described for this device, as it's a substantially equivalent determination based on non-clinical testing.
Here's the information extracted and organized according to your request:
Acceptance Criteria and Device Performance for MIVI Q Distal Access Catheter
1. Table of Acceptance Criteria and Reported Device Performance
For Bench Testing (Non-Clinical Performance):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | The device must meet dimensional specifications. | Pass |
| System Introduction (Simulated Use) | The device must function as intended. | Pass |
| Liquid Leakage under Pressure | The device must hold a hydrostatic pressure. | Pass |
| Tensile Strength | Tensile strength pull force minimum must be met. | Pass |
For Biocompatibility Testing:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Non-toxic to cells (determined by specific extract and cell line). | PASS |
| Irritation or Intracutaneous Reactivity | No significant irritation or reactivity in vivo (animal model). | PASS |
| Sensitization | No significant sensitization reaction (animal model). | PASS |
| Acute Systemic Toxicity | No acute systemic toxicity (animal model). | PASS |
| Pyrogenicity (Material-mediated) | Non-pyrogenic (no fever-inducing substances in vivo). | PASS |
| Hemolysis | No significant hemolysis (destruction of red blood cells) in vitro. | PASS |
| Unactivated Partial Thromboplastin Time | No significant impact on blood clotting time (in vitro). | PASS |
| Complement Activation | No significant complement activation (immune response) in vitro. | PASS |
For Sterilization and Shelf Life:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization | Confirmed sterility of the final packaging configuration and method. | Met specification |
| Shelf Life and Expiration Dating | Maintain performance and integrity for the specified period. | 3 years (same as predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical (bench and biocompatibility) test. Such details are typically found in the full test reports, not in the summary document.
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting (in vitro or in animal models), not on human subjects. Therefore, there is no country of origin for human patient data. The provenance of the data is the laboratory where the tests were performed. The studies are prospective in the sense that they were designed and executed to test the characteristics of the MIVI Q Distal Access Catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The "ground truth" in this context is established by objective measurements and standardized test methods (e.g., ISO standards for biocompatibility, engineering specifications for bench tests), not by expert consensus on clinical data. No human "experts" were used to establish ground truth for this type of non-clinical testing.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for interpreting imaging or clinical outcomes where there might be inter-reader variability. For non-clinical bench and biocompatibility tests, results are typically objective (e.g., a tensile strength value, a cytotoxicity rating) and do not require expert adjudication in this manner.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The MIVI Q Distal Access Catheter is a physical medical device (a catheter), not an AI algorithm, and therefore does not involve human readers interpreting output from an AI system. The submission is for substantial equivalence of a physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As explained above, this device is a physical catheter, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Bench Testing: Ground truth is defined by engineering specifications and objective physical measurements (e.g., specified dimensions, force thresholds, pressure integrity).
- Biocompatibility Testing: Ground truth is established by standardized biological assays and observation in animal models and in vitro systems, as per recognized international standards (e.g., ISO 10993 series). The results are objective measurements against defined pass/fail criteria.
8. The sample size for the training set
This is not applicable. There is no AI algorithm involved that requires a training set. The "study" here consists of non-clinical performance and biocompatibility testing of the physical catheter.
9. How the ground truth for the training set was established
This is not applicable, as there is no AI algorithm or training set.
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